Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

UniCel DxC 660i Recalled by Beckman Coulter Inc. Due to When racks are front-loaded onto the sample presentation...

Date: December 5, 2018
Company: Beckman Coulter Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Inc. directly.

Affected Products

UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102

Quantity: 0

Why Was This Recalled?

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Where Was This Sold?

This product was distributed to 26 states: AL, AK, CA, FL, GA, ID, IL, IN, KY, LA, MA, MI, MN, MS, NJ, NY, NC, ND, OH, PA, TN, TX, WA, WV, WI, DC

Affected (26 states)Not affected

About Beckman Coulter Inc.

Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report